TRUFILL n-BCA Liquid Embolic System 의 안전성 경고

Safety alert

2014-01-23

2014-01-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140123.html

Medical device safety alert: codman neuro trufill n-bca liquid embolic system the united states food and drug administration (fda) has issued a medical device safety alert concerning trufill n-bca liquid embolic system [product code: 631400 & 631500], manufactured by codman neuro. according to the fda, trufill n-bca is indicated for embolization of cerebral arteriovenous malformations (avms) when presurgical devascularization is desired. in october 2013, the manufacturer identified an incorrect statement in the product's instructions for use (ifu) that described suggested mixing ratios for use in certain treatment conditions. the manufacturer is informing physicians of this incorrect statement and updating the product's ifu. the product's ifu incorrectly noted: "a 2:1 (67% ethiodized oil / 33% nbca) for feeding pedicle injections close to the nidus at high flow rates where venous opacification occurs on contrast injections within 1/2 second." the correct information should have stated: "a 2:1 (67% ethiodized oil / 33% nbca) for intranidal injections without av fistulae or high flow rates in order to more deeply penetrate the nidus." the use of incorrectly mixed product can result in the liquid mixture solidifying too slowly in unintended areas, which may lead to embolization or reflux into arteries and pulmonary vessels. this could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death. the manufacturer advises all affected users to review the correction notice and other product literature to ensure proper mixing procedures are followed. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to fda websites:http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm382556.Htm http://www.Fda.Gov/safety/recalls/ucm382496.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 january 2014.